ttubular- Re the 2037 patent (036): This is from the 4th quarter earnings call on Feb 28, 2022:
Aurinia Pharmaceuticals Inc.'s (AUPH)
CEO Peter Greenleaf on Q4 2021
Results - Earnings Call Transcript
Feb. 28, 2022 10:27 AM ET |
Maury Raycroft
Got it. Okay. And maybe just quick question, in your 10-K, you note that Sun filed
an IPR against your 036 patent. And I'm just wondering if you can comment on your
latest thoughts on IP positioning and also this particular issue?
Peter Greenleaf
Sure. And let me actually take a minute to address this one. I want to thank you for
the question. We did receive notice of an inter partes review, or IPR, petition being
filed on February 24 with respect to our patent that has claims directed at
LUPKYNIS dosing protocol for lupus nephritis used in our clinical trials.
As you all recall, that patent has a term extending out to December of 2037. At this
stage, it's really too preliminary to give a full assessment of this IPR as a position --
a petition that was filed from Sun Pharmaceuticals who you all may recall, if you've
been reading our Ks, we are suing for patent infringement in a separate matter,
which I'll talk about in a second, was really just received.
So we're looking at it, but we're confident in our process to prosecute all our
patents. This patent in particular, had significant review, as we've mentioned
previously at the U.S. Patent and Trade Office before being approved as being
actual valid patent by that office. We're putting together our reply. And as I've said
before, we'll vigorously defend this patent and other challenges we get, again, from
any party that bring any challenge to our patents.
With respect to the separate litigation we have with Sun that I just mentioned, and
as has been disclosed in our 10-K, in December of 2020, we actually commenced
on an action in the U.S. District Court, New Jersey against Sun and certain of their
affiliates, and in summary, the action is a claim for patent infringement under U.S.
patent laws arising relating to Sun's CEQUA product, which is a C&I
immunosuppressant ophthalmic solution prior to the expiration of our patents
relating to voclosporin's ophthalmic solution.
So basically, in our action, we requested relief in the form of an order confirming
that Sun has infringed those patents and injunction preventing Sun for
manufacturing, using or selling CEQUA and monetary relief, including costs.
Obviously, Sun has responded by denying infringement and/or asserting that the
patents here are valid. We and Sun actually have exchanged initial pleadings and
patent disclosures, and we're in the process of what lawyers qualify as claim
construction, and that's all ongoing. Trial action on this one is probably somewhere
on or around March of 2023. So that gives the full backgrounder on the previously
mentioned Sun litigation and the IPR side of the equation.
Maury Raycroft
Got it. Okay. That’s helpful. Thanks for taking my questions
